Etanercept SFP in RA Patients

NCT00413452 | Completed Phase 3

• 1 other identifier: 20060104
• Study Type: interventional
• Target: 224
• Locations: 0 countries
• Sites: N/A

Brief Summary

Purpose of this study is to evaluate the immunogenicity and overall safety of etanercept SFP therapy administered once weekly for 24 weeks to subjects with rheumatoid arthritis.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; Etanercept; Enbrel; Amgen

Outcome Measures

Primary Outcomes (1)

• Etanercept seroreactivity response (ie, development of anti-etanercept antibodies) to etanercept (manufactured using the SFP)

  24 weeks

Secondary Outcomes (3)

• Etanercept seroreactivity response to etanercept (manufactured using the SFP)

  week 12

• neutralizing antibodies to etanercept

  week 12 and 24

• Adverse events, serious adverse events (SAEs), serious infections and safety laboratory assessments

  week 24

Study Arms (1)

50 mg

EXPERIMENTAL

50 mg once weekly

Drug: Etanercept

Interventions

Etanercept DRUG

50 mg once weekly

50 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women 18 years of age or older who have RA, as defined by the ACR criteria for classification of RA
• Naïve to etanercept therapy
• Able to self-inject investigational product or have a designee who can do so

You may not qualify if:

• Receipt of Corticosteroids\> 10 mg/day of prednisone (or its equivalent) during 14 days befor 1st dose of investigational product
• Receipt of MTX witin 30 days of 1st dose of investigational product
• Receipt of an other investigational drug within 30 days of 1st dose
• Receipt of TNF inhibitor therapy within 90 days of 1st dose
• Receipt of cyclophosphamide within 6 mo of 1st dose
• Current use of nonsteroidal anti-inflammatory drugs (NSAIDs) greather than the maximum recommended dose in the product info sheet
• Current use of insulin
• gnificant concurrent medical condition

Sponsors & Collaborators

• Amgen: lead
• Wyeth is now a wholly owned subsidiary of Pfizer: collaborator

Related Links

• Notice regarding posted summaries of trial results
• To access clinical trial results information click on this link
• FDA-approved Drug Labeling
• AmgenTrials clinical trials website

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 15, 2006
• First Posted: December 19, 2006
• Study Start: December 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: October 1, 2007
• Last Updated: February 13, 2009

Record last verified: 2009-02